510(k) Report

FDA applicant

Michclone Associates, Inc.

Detroit, MI3 decisions1984–19873 recalls

FDA records 3 decisions for Michclone Associates, Inc. (Detroit, MI) from 1984 to 1987: 3 510(k) clearances. Most are in product codes GHM (Test, Sickle Cell) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Michclone Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Michclone Associates, Inc. since 2007.

Recalls per year

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Michclone Associates, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GHMTest, Sickle Cell2decisions
  • CHHEnzymatic Esterase--Oxidase, Cholesterol1decision

What has FDA decided for it lately?

  • K871676Enzymatic Cholesterol Reagent SetMichclone Associates, Inc. · 1987
  • K860812Sickle Cell Reagent SetMichclone Associates, Inc. · 19863 recalls
  • K842955Sickle-Heme a/S Heterozygous ControlMichclone Associates, Inc. · 1984

All 3 as Michclone Associates, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K860812Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the…Feb 23, 2012
  • K860812Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test…Feb 23, 2012
  • K860812BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100…Feb 23, 2012